Anti-buckling mechanisms for catheters

ABSTRACT

A device is provided for preventing buckling of a flexible elongate member during insertion of the flexible elongate member. The device includes a support frame comprising a first end, a second end, and multiple pairs of support members. The support frame is configured to reversibly move from a collapsed configuration to an expanded configuration when the first and second ends are moved away from each other. The device also includes multiple open channels coupled to the multiple pairs of support members of the support frame. The multiple open channels are configured to allow the flexible elongate member to be top loaded into the multiple open channels. Also, the multiple open channels are maintained in an axial alignment as the support frame is moved between the expanded and collapsed configurations.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.61/993,370, Anti-Buckling Channel, filed May 15, 2014, which isincorporated by reference in its entirety herein; U.S. ProvisionalApplication No. 62/014,189, Anti-Buckling Mechanism for Catheters, filedJun. 19, 2014, which is incorporated by reference in its entiretyherein; and U.S. Provisional Application No. 62/057,356, Anti-BucklingMechanism for Catheters, filed Sep. 30, 2014, which is incorporated byreference in its entirety herein.

This application is related to U.S. Nonprovisional application Ser. No.13/174,563, Anti-Buckling Mechanisms and Methods, filed Jun. 30, 2011,which is incorporated by reference in its entirety herein.

BACKGROUND

Robotic surgical systems and devices are well suited for use inperforming minimally invasive medical procedures, as opposed toconventional techniques that may require large incisions to open thepatient's body cavity to provide the surgeon with access to internalorgans. For example, a robotic surgical system may be utilized tofacilitate imaging, diagnosis, and treatment of tissues which may liedeep within a patient, and which may be preferably accessed only vianaturally-occurring pathways such as blood vessels or thegastrointestinal tract. One such robotic surgical system that may beutilized in such a minimally invasive procedure is a robotic cathetersystem. A robotic catheter system utilizes a robot, external to thepatient's body cavity, to insert a catheter through a small incision ina patient's body cavity and guide the catheter to a location ofinterest.

Catheters by design are typically made of a flexible material thatallows for maneuverability through the patient's body cavity, especiallythe complex tortuosity of blood vessels. The flexible nature of thecatheter can cause the catheter to bend, flex, or buckle in anundesirable manner at a point external to the patient's body cavity whenforce is exerted to insert the catheter into and throughout the bodycavity.

Current anti-buckling devices may protect the catheter from undesiredflexing and bending, but typically are cost-prohibitive as theirstructures are complex, requiring multiple components and increasedassembly time. Further, known anti-buckling mechanisms often must beplaced within the sterile field, requiring disposal of the anti-bucklingmechanism at the conclusion of each procedure. Accordingly, there is aneed for alternative anti-buckling mechanisms.

SUMMARY

In one aspect, a device for preventing buckling of a flexible elongatemember during insertion of the flexible elongate member may include asupport frame having a first end, a second end, and multiple pairs ofsupport members. The support frame is configured to reversibly move froma collapsed configuration to an expanded configuration when the firstand second ends are moved away from each other. The device may furtherinclude multiple open channels coupled to the multiple pairs of supportmembers of the support frame. The multiple open channels are configuredto allow the flexible elongate member to be top loaded into the multipleopen channels. Also the multiple open channels are maintained in anaxial alignment as the support frame is moved between the expanded andcollapsed configurations.

In some embodiments, each pair of support members is an alignmentmember. In some such embodiments, each alignment member defines one ofthe multiple open channels. In some such embodiments, each alignmentmember includes a slidable member configured to slide laterally withrespect to the open channel to close or open the open channel. In someembodiments, each of the multiple open channels is secured to one of thepairs of support members, such that each open channel is maintained in asubstantially fixed rotational position with respect to itscorresponding pair of support members.

In some embodiments, the device may further include the flexibleelongate member, and each of the multiple open channels may have adiameter that is larger than an outer diameter of the flexible elongatemember. Optionally, the device may also include at least one coverconfigured to selectively cover one of the multiple open channels. Insome embodiments, the cover is slidably connected to the one of themultiple open channels. Also optionally, the device may also includemultiple alignment members, each defining one of the multiple openchannels, where the cover is configured to slide laterally with respectto the one of the multiple open channels. In some embodiments, adiameter of each of the multiple open channels is sufficiently largerthan a diameter of the flexible elongate member to allow the elongatemember to maintain the axial alignment when the first and second endsare moved with respect to each other. In some embodiments, the devicemay also include a first coupler positioned on the first end of thesupport frame, and a second coupler positioned on the second end of thesupport frame, where the second coupler is configured to position theflexible elongate member.

In another aspect, a device for preventing buckling of a flexibleelongate member during insertion of the flexible elongate member mayinclude a support frame as descried above, which includes a first end, asecond end, and multiple pairs of support members, and wherein thesupport frame is configured to reversibly move from a collapsedconfiguration to an expanded configuration when the first and secondends are moved away from each other. The device may further includemultiple alignment members coupled to the multiple pairs of supportmembers of the support frame, where the multiple alignment members areconfigured to receive the flexible elongate member.

In some embodiments, the multiple pairs of support members and themultiple alignment members are coupled to each other through anaxially-centered pivot point. Some embodiments may further include anaperture in each of the multiple alignment members for receiving theflexible elongate member. In some embodiments, each aperture is locatedat a position off-center from a centerline axis of the anti-bucklingdevice. In some embodiments, each aperture is rotationally constrained.In some embodiments, each alignment member includes a top element and abottom element, and the bottom element includes rails for slidablycoupling to the top element. In some embodiments, each alignment membercomprises a slot for slidably coupling to a pin disposed on the multiplepairs of support members to couple the alignment member to the multiplepairs of support members.

These and other aspects and embodiments will be described in furtherdetail below, in reference to the attached drawing figures.

BRIEF DESCRIPTION OF THE DRAWINGS

While the claims are not limited to the illustrated embodiments, anappreciation of various aspects is best gained through a discussion ofvarious examples thereof. Referring now to the drawings, illustrativeexamples are shown in detail. Although the drawings represent theexemplary illustrations disclosed herein, the drawings are notnecessarily to scale and certain features may be exaggerated to betterillustrate and explain an innovative aspect of an example. Further, theexamples described herein are not intended to be exhaustive or otherwiselimiting or restricting to the precise form and configuration shown inthe drawings and disclosed in the following detailed description.Exemplary illustrations of the present invention are described in detailby referring to the drawings as follows.

FIG. 1A is a perspective view of a robotically controlled surgicalsystem, according to one embodiment;

FIG. 1B is a perspective view of an exemplary catheter assembly of thesurgical system of FIG. 1A;

FIG. 1C is a perspective view of an exemplary catheter assembly with aprior art anti-buckling mechanism;

FIG. 2 is a top view of a portion of an exemplary anti-bucklingmechanism with a top-loadable coupler, according to one embodiment;

FIGS. 3-5 are perspective views of an exemplary anti-buckling mechanism,in different configurations, which may be used with a roboticallycontrolled surgical system, according to one embodiment;

FIGS. 6-8 are top, top and perspective views, respectively, of theanti-buckling mechanism of FIGS. 3-5;

FIGS. 9-11 are perspective views of an exemplary anti-bucklingmechanism, in different configurations, which may be used with arobotically controlled surgical system, according to an alternativeembodiment;

FIGS. 12 and 13 are top views of the anti-buckling mechanism of FIGS.9-11;

FIGS. 14 and 15 are perspective views of an exemplary anti-bucklingmechanism, in different configurations, which may be used with arobotically controlled surgical system, according to an alternativeembodiment;

FIG. 16A is a perspective view of an exemplary anti-buckling mechanismthat may be used with a moveable eyelet, which may be used with arobotically controlled surgical system, according to one embodiment;

FIG. 16B is a perspective view of an exemplary anti-buckling mechanismwith a moveable eyelet, which may be used with a robotically controlledsurgical system, according to an alternative embodiment;

FIG. 17 is a perspective view of an exemplary anti-buckling mechanismwith a slider, which may be used with a robotically controlled surgicalsystem, according to another alternative embodiment;

FIG. 18 is a perspective view of an exemplary anti-buckling mechanismwith a pinned connection, which may be used with a roboticallycontrolled surgical system, according to another alternative embodiment;

FIG. 19 is a partial top view of an anti-buckling mechanism with avariable eyelet, which may be used with a robotically controlledsurgical system, according to one embodiment;

FIGS. 20 and 21 are perspective views of the anti-buckling mechanism ofFIG. 19;

FIGS. 22-24 are top views of an anti-buckling mechanism with an offsetvariable eyelet, which may be used with a robotically controlledsurgical system, according to one embodiment;

FIGS. 25 and 26 are perspective and partial cross-sectional views,respectively, of an anti-buckling mechanism with geared beams, which maybe used with a robotically controlled surgical system, according to oneembodiment;

FIG. 27 is a cutaway perspective view of an exemplary instrument driverhaving an anti-buckling support incorporated within the driver,according to one embodiment;

FIG. 28 is an enlarged view of the cutaway of the exemplary instrumentdriver of FIG. 27, according to one embodiment;

FIG. 29 is another cutaway perspective view of the exemplary instrumentdriver of FIG. 27, according to one embodiment;

FIG. 30 is another cutaway perspective view of the exemplary instrumentdriver of FIG. 27, including an upper deck, according to one embodiment;

FIG. 31 is another cutaway perspective view of the exemplary instrumentdriver of FIG. 27, illustrating another view of an upper deck, accordingto one embodiment;

FIG. 32 is another cutaway perspective view of the exemplary instrumentdriver of FIG. 27, providing an enlarged view of a retractedanti-buckling mechanism within the instrument driver, according to oneembodiment;

FIG. 33 is another cutaway perspective view of the exemplary instrumentdriver of FIG. 27, providing an enlarged view of a partially extendedanti-buckling mechanism within the instrument driver, according to oneembodiment;

FIG. 34 is another cutaway perspective view of the exemplary instrumentdriver of FIG. 27, providing an enlarged view of the retractedanti-buckling mechanism within the instrument driver, according to oneembodiment;

FIG. 35 is a perspective view of the exemplary instrument driver of FIG.27, illustrating the upper deck and external cover, according to oneembodiment;

FIG. 36 is an enlarged perspective view of the exemplary instrumentdriver of FIG. 27, illustrating the upper deck and external cover,according to one embodiment;

FIG. 37 is a perspective view of an exemplary anti-buckling mechanismpositioned to provide anti-buckling support to an exemplary elongatemember, which in turn is connected to a splayer, according to oneembodiment;

FIG. 38 is a top view of the exemplary anti-buckling mechanism of FIG.37, illustrated without the elongate member and splayer;

FIG. 39 is a perspective view of the exemplary anti-buckling mechanismof FIGS. 37 and 37, illustrated without the elongate member and splayer;

FIG. 40 a schematic illustration of an exemplary anti-buckling support,according to one embodiment;

FIG. 41 is perspective view of an anti-buckling support structure,according to one embodiment;

FIG. 42 is an end-on, cross-sectional view of an exemplary sheath rail,according to one embodiment;

FIG. 43 is a perspective view of the sheath splayer of FIG. 42,including a rear roller assembly, according to one embodiment;

FIG. 44 is a perspective view of a roller assembly mounted to a sheathrail, according to one embodiment;

FIG. 45 is an enlarged perspective view of the leader splayer and leaderrail mount, according to one embodiment;

FIG. 46 is a perspective view of another exemplary anti-bucklingmechanism, including a long channel extending between a leader splayerand a sheath splayer, according to one embodiment;

FIGS. 47A and 47B are perspective and end-on cross-sectional views,respectively, of another exemplary anti-buckling mechanism, including along channel extending between a leader splayer and a sheath splayer,and FIG. 47B further shows an exemplary elongate member installed,according to one embodiment;

FIG. 48 is a perspective view of an exemplary sterile drape adapter thatis coupled to the long channel of FIGS. 47A and 47B, according to oneembodiment;

FIGS. 49A and 49B are perspective views of another exemplaryanti-buckling mechanism, which includes a long channel, whichencapsulates the catheter and employs separate rails for the sheathcatheter and leader, according to an alternative embodiment.

DETAILED DESCRIPTION

Referring now to the discussion that follows and to the drawings,illustrative approaches to the disclosed assemblies are shown in detail.Although the drawings represent some possible approaches, the drawingsare not necessarily to scale, and certain features may be exaggerated,removed, or partially sectioned to better illustrate and explain thepresent disclosure. Further, the descriptions set forth herein are notintended to be exhaustive or otherwise limit or restrict the claims tothe precise forms and configurations shown in the drawings and disclosedin the following detailed description.

Exemplary illustrations are generally directed to an anti-bucklingmechanism for use with a medical device, including but not limited touse of the anti-buckling mechanism to stabilize a flexible catheterexternal to a patient's body cavity. The anti-buckling mechanism maytake many different forms and may include multiple and/or alternatecomponents and facilities. The exemplary components illustrated are notintended to be limiting. Indeed, additional or alternative componentsand/or implementations may be used.

System

Referring to FIG. 1A, a robotically controlled surgical system (S), inwhich various alternative arrangements of exemplary apparatuses may beimplemented, includes a robotic catheter assembly (A) having a first orouter robotic steerable component, otherwise referred to as a sheathinstrument 30 (generally referred to as “sheath” or “sheath instrument”)and/or a second or inner steerable component, otherwise referred to as arobotic catheter or guide or catheter instrument 18 (generally referredto as “catheter” or “catheter instrument”). The sheath instrument 30 andcatheter instrument 18 are controllable using a robotic instrumentdriver 16 (generally referred to as “instrument driver”). During use, apatient is positioned on an operating table or surgical bed 22(generally referred to as “operating table”), to which a roboticcatheter assembly (A) is coupled or mounted. In the illustrated example,the system (S) further includes an operator workstation 2, anelectronics rack 6 and associated bedside electronics box, a setup jointmounting brace 20, and the instrument driver 16. In use, a surgeon ispositioned at the operator workstation 2 and can monitor the surgicalprocedure and patient vitals, and control one or more catheter devices,remote from the patient.

While various system (S) components with which embodiments describedherein may be implemented are illustrated in close proximity to eachother in FIG. 1, embodiments may also be implemented in systems (S) inwhich components are separated from each other in separate rooms,buildings, and/or geographical locations. For example, the instrumentdriver 16, operating table 22, and bedside electronics box may belocated in a surgical area with the patient, and the operatorworkstation 2 and the electronics rack 6 may be located outside thesurgical area and behind a shielded partition. System (S) components mayalso communicate with other system (S) components via a network to allowfor remote surgical procedures during which the surgeon may be locatedat a different location, for example in a different building or at adifferent hospital, using a communication link that transfers signalsbetween the operator control station 2 and the instrument driver 16.System (S) components may also be coupled together via a hard-wiredconnection 14, for example multiple cables or other suitable connectorsto provide for data communication, or one or more components may beequipped with wireless communication components to reduce or eliminatecables 14. In this manner, a surgeon or other operator may control asurgical instrument while being located away from or remotely fromradiation sources, thereby decreasing the operator's exposure toradiation.

With further reference to FIG. 1B, an instrument assembly (A) comprisedof a sheath instrument or splayer 30 and an associated guide or catheterinstrument or splayer 18 is mounted to mounting plates 37, 38 on a topportion of the instrument driver 16. Embodiments described herein aresimilar to those described in detail in U.S. patent application Ser.Nos. 11/678,001, 11/678,016, and 11/804,585, each of which isincorporated by reference herein in its entirety.

FIG. 1C illustrates further detail of the instrument assembly (A) ofFIG. 1B. The instrument driver 16 includes the catheter instrument 18for positioning a catheter 17, and the sheath instrument 30 forpositioning a sheath 31 that is placed coaxially around the catheter 17.In the illustrated embodiments, the sheath instrument 30 is moveablerelative to the catheter instrument 18. The sheath and catheterinstruments 30 and 18 each have four drivable elements for moving thecatheter 17, and the sheath 31, respectively, in different directions.However, in other embodiments, the number of drivable elements in eachof the sheath and catheter instruments 30 and 18 may be less than fouror more than four. The instrument driver 16 may also include twoanti-buckling mechanisms 20 a, 20 b for preventing the buckling of thecatheter 17, and the buckling of the sheath 31, respectively, duringuse. Various exemplary arrangements of the anti-buckling mechanisms willbe described in further detail below.

Anti-buckling mechanisms 20 a, 20 b are configured to detachably coupleto the catheter instrument 18 and sheath instrument 30, respectively.The anti-buckling mechanism 20 a may be configured with a first end 102(shown in FIG. 1C) for detachably coupling to the catheter instrument18, and a second end 104 for detachably coupling to the sheath assembly(shown in FIG. 1C). During use, the anti-buckling mechanism 20 a isplaced around an elongate member, for example the catheter 17. Theanti-buckling mechanism 20 a is then secured to the catheter instrument18 at the first end 102, and to the sheath instrument 30 at the secondend 104. The anti-buckling mechanism 20 a provides support along thelength of the catheter 17 (or other elongate member) between theinstruments 18, 30, such that as the catheter 17 is pushed towards thepatient (resulting in the catheter 17 being compressed), and thecatheter 17 is prevented from buckling.

The anti-buckling mechanism 20 a further includes a first coupler 19operatively connected to the first end 102 and a second coupler 21operatively connected to the second end 104. The first coupler 19 isconfigured to detachably mate with an anchor element of the catheterinstrument 18. The second coupler 21 is configured to detachably matewith a mounting element of the sheath instrument 30. An exemplaryconfiguration of the first coupler and anchor element and the secondcoupler and mounting element is shown and described in U.S. patentapplication Ser. No. 13/174,563, the contents of which are incorporatedby reference in its entirety.

Referring now to FIG. 2, in some embodiments, an anti-buckling mechanism40 may include a coupler 44 (or multiple couplers 44) that aretop-loadable, meaning that the catheter 17 or other elongate member canbe loaded into the anti-buckling mechanism 40 from the top. This isopposed to, for example, threading the catheter 17 through a hole at oneend of an alternative embodiment anti-buckling mechanism. The coupler 44may be configured in a C shape, for example, such that the there is aslot or opening 44 in the top of the coupler 44 for receiving thecatheter 17 or other elongate member. In alternative embodiments, thecoupler 44 may be a rigid connector, and the catheter 17 may passthrough a top-loadable eyelet (not shown) on the coupler 44. The firstalignment member 46 of the support frame of the anti-buckling mechanism40 may also include a top loadable eyelet 48 to facilitate top loadingof the elongate member 17.

The anti-buckling mechanism 20 b is configured to detachably couple tothe sheath instrument 30 and a patient or another device, for example astabilizer (not shown) during use. As shown in FIG. 1C, theanti-buckling mechanism 20 b has a first end 35 for detachably couplingto the sheath instrument 30, and a second end 33 for detachably couplingto the stabilizer. During use, the stabilizer is attached to a patient'sskin, and the anti-buckling device 20 b is placed around the sheath 31.One such exemplary stabilizer is shown and described in U.S. patentapplication Ser. No. 13/174,563. The distal end of the sheath 31 is theninserted into the patient through the stabilizer. The anti-bucklingdevice 20 b is secured to the sheath instrument 30 at the first end 35,and to the stabilizer at the second end 33. The anti-buckling device 20b provides support along the length of the sheath 31 between thestabilizer and the sheath instrument 30, such that as the sheath 31 ispushed towards the patient (resulting in the sheath 31 beingcompressed), and the sheath 31 is prevented from buckling.

The anti-buckling mechanism 20 b further includes a first coupler 23operatively connected to the first end 35 and a second coupler 25operatively connected to the second end 33. The first coupler 23 isconfigured to detachably mate with a mounting element of the sheathinstrument 30. The second coupler 25 is configured to detachably matewith a patient or another device, for example a stabilizer mounted tothe patient. Alternatively, the second coupler 25 may be configured todetachably mate with an introducer sheath at the insertion site. Anexemplary configuration of the first coupler 23 and mounting element andthe second coupler 25 and stabilizer is shown and described in U.S.patent application Ser. No. 13/174,563.

Scissor-Like Anti-Buckling Mechanisms

FIGS. 3-8 illustrate different views of an exemplary embodiment of ananti-buckling mechanism 100 in further detail, with the first and secondcoupling elements being omitted. The anti-buckling mechanism 100includes multiple support members 108, 110 and an alignment member 106,coupled between a proximal end 109 and a distal end 111 of theanti-buckling mechanism 100, which are connected together to create aselectively expandable scaffolding structure. First support members 108are positioned on one side of the anti-buckling mechanism 100, andsecond support members 110 are positioned on the opposite side of theanti-buckling mechanism 100, to create a support frame having ascissor-like configuration having a first end 133 and a second end 135.The alignment members 106 are located on top of the first and secondsets of support members 108, 110. Alternatively, in some embodiments,the alignment members are located between or underneath the first andsecond sets of support members

Each alignment member 106 includes an eyelet 112 therethrough, as shownin FIG. 8, or positioned on a top surface 114 thereof, as shown in FIGS.3-5. The alignment member 106 is generally configured to orient theeyelet 112 such that eyelets 112 defined by a series of alignmentmembers 112 are maintained in an alignment, thus facilitating support ofan elongate member, for example a catheter. While eyelet 112 is shown asbeing integrally formed with the top surface 114 of the alignment member106, in alternative embodiments eyelet 112 may be separately formed andattached to top surface 114 of the alignment member 106 or a bottomsurface of the anti-buckling mechanism 100 or an eyelet or hole passingthrough the alignment member 106. Further, in one exemplaryconfiguration, the eyelet 112 is slightly offset from a center of thealignment member 106. The eyelet 112 of alignment member 106 functionsto receive an elongate instrument, for example a catheter, sheath,guidewire, or any combination thereof.

Alignment member 106 further includes a slot 116 positioned adjacent toone end 118 and extending longitudinally toward eyelet 112. In oneconfiguration, slot 116 extends through both the top and bottom surfaces114 and 120, respectively, of alignment member 106. However, inalternative embodiments slot 116 is not required to extend throughalignment member 106 and thus may only be open on bottom surface 120 ortop surface 114.

Alignment member 106 may further include an attachment hole 122, thefunction of which will be described in greater detail below. In oneexemplary arrangement, attachment hole 122 is positioned on end 124,which is opposite end 118.

In one exemplary embodiment, the second support member 108 includesthree attachment holes (only 126 being visible in FIGS. 3-5). A firstattachment hole 126 is positioned on one end 130 of second supportmember 108. A second attachment hole (not shown) is positioned on anopposite end 132 of second support member 108. A third attachment hole(not shown) is positioned between the ends 130 and 132. The attachmentholes 126 are configured to receive pins, which will be explained infurther detail below. The pin joints may also be replaced with othertypes of joints, for example ball and socket joints or knuckle joints.

The second support member 110 is positioned between alignment member 106and first support member 108. The second support member 110 alsoincludes three attachment holes 136 (only one of which is visible),which receive pins 138, as shown in FIG. 6. One pin 138 a extendsupwardly from a top surface 140 of second support member 110. Pin 138 ais configured to be received within the slot 116. Pin 138 a thusoperatively connects second support member 110 to alignment member 106.

Pin 134, as shown in FIG. 7, is configured to hingedly connect the firstand second support members 108 and 110. More specifically, in oneexemplary embodiment, pin 134 is received in attachment holes 136(formed in second support member 110), and a corresponding attachmenthole (not shown) in first support member 108. Another pin 134 (see FIGS.6 and 7) hingedly connects the alignment member 106 and the secondsupport member 110 together, such that expanding the anti-bucklingdevice slides pin 138 a in slot 116 towards the centerline axis ofanti-buckling device, and collapsing the anti-buckling device slides pin138 a in slot 116 outwardly away from the centerline axis of theanti-buckling device. Further, as described above, pin 138 a operativelyconnects second support member 110 to alignment member 106.

The proximal end 109 of the anti-buckling mechanism 100 is configuredsuch that alignment member 106 receives a pin 138 b (visible in FIGS. 6and 7) extending from attachment hole 126 (See FIGS. 3-5). Pins 138 a,138 b may be longer than pin 134, to span the distance between a topsurface of first support member 108 and at least a portion of thethickness of the alignment member 106, to be slidingly received in theslot 116, as shown in FIGS. 6 and 7.

The interaction between pins 138 a and 138 b on support members 108, 110and slots 116 on alignment members 106 allows successively arrangedsupport members 108, 110 to be spaced apart from one another, therebyproviding a frame to prevent buckling of a catheter 17 and/or sheath 31.More specifically, with reference to FIG. 6, when the anti-bucklingmechanism 100 is moving toward a compressed configuration, pins 138 a,138 b are disposed adjacent end 118. When the pins 138 a, 138 b arepositioned at the respective ends 118 of the slots 116, the supportframe is collapsed or substantially so, and the successive supportmembers 108, 110 and alignment member 106 are positioned adjacent to oneanother (see FIG. 3, for example). In contrast, when the anti-bucklingmechanism 100 is in a fully expanded configuration, as shown in FIG. 7,the pins 138 a, 138 b have traveled the length of the respective slots116, toward the center of the anti-buckling mechanism. In thisconfiguration, the successively arranged support members 108, 110 arespaced apart from one another. More specifically, support members 108and 110 are pivoted about the pins 134 disposed in the center and at theend 124 of support members 108 and 110, thereby forcing support members108, 110 to be spaced apart from one another. While the precedingdescription identifies alignment member 106 positioned on top of supportmembers 108 and 110, the alignment member 106 may also be positionedunder or in between support members 108 and 110, as shown in FIG. 8.

This arrangement of anti-buckling mechanism 100 ensures that theindividual eyelets 112 of successive support members 108, 110 andalignment members, 106 are automatically aligned to form a pathway forthe catheter 17 and/or sheath 30. Thus, the design of anti-bucklingmechanism 100 is more robust in negating eyelet misalignment, therebyavoiding damage to the catheter 17 and/or sheath 30. Further, theabove-described design also provides sufficient rigidity to the catheter17 and/or sheath 30 during use, but is configured to yield a lighterdesign, with minimal components that has fewer tendencies to bind.Accordingly, anti-buckling mechanism 100 is cost-effective tomanufacture, while reducing potential failure points.

A further alternative embodiment for an anti-buckling mechanism 300 isillustrated in FIGS. 9-13. FIG. 9 illustrates the anti-bucklingmechanism 300 in a compressed arrangement, while FIGS. 10-13 illustratethe anti-buckling mechanism 300 in an expanded arrangement. Theanti-buckling mechanism 300 includes multiple successively arrangedfirst and second support members 308, 310, respectively, and alignmentmember 306 coupled between a proximal end 309 and a distal end 311 ofthe anti-buckling mechanism 300. Alignment members 306 are on one sideof the anti-buckling mechanism 300, and the first support members 308are on the opposite side of the anti-buckling mechanism 300. Secondsupport members 310 are located between the alignment members 306 andfirst set of support members 308. In the illustrated embodiments,alignment member 306 and support members 308 and 310 cooperate to createa scissor-like scaffolding mechanism.

As shown in FIGS. 11 and 12, alignment member 306 is comprised of twomating components; a bottom element 312 and a top element 314. Bottomelement 312 is defined by an end 316 that includes an attachment hole318 therein. A portion of bottom element 312 is formed with rails 320.Rails 320 extend from a wall member 322 to an end 324 of bottom element312, such that compressing the anti-buckling mechanism drives topelement 314 on the rails 320 to connect with bottom element 312, asshown in FIG. 11.

Top element 314 has a bottom surface that is configured to matinglyengage with rails 320. In one exemplary arrangement, the bottom surfaceof top element 214 includes a center projection that is configured toslide between rails 320. In another exemplary arrangement, the bottomsurface of top element includes groove members that receive the rails320 therein such that the top element 214 may slide with respect tobottom element 312.

Top element 314 is defined by an end 326 that also includes anattachment hole 318 therein. An inwardly facing wall member 328 isformed in the bottom surface of top element 314, adjacent end 326.

Each top element 314 of alignment member 306 further includes an eyelet330 positioned on a top surface 332 thereof. Eyelet 330 is positionedadjacent an end 334 of top element 314. While eyelet 330 is shown asbeing integrally formed with the top surface 332 of the top element 314of the alignment member 306, it is understood that eyelet 330 may alsobe separately formed and attached to top surface 332. Eyelet 330functions to receive an elongate member, for example a catheter, sheath,and guidewire, or any combination thereof.

In one exemplary embodiment, the first support member 308 includes threeattachment holes 336. A first attachment hole 336 is positioned on oneend 338 of first support member 308. A second attachment hole 336, asshown in FIG. 9, is positioned on an opposite end 340 of first supportmember 308. A third attachment hole (not shown) is positioned betweenthe ends 338 and 340, at approximately the center of the first supportmember 308. The attachment holes 336 are configured to receive pins (notshown), in a similar manner that has been described above in connectionwith anti-buckling mechanisms 100 and 200.

The second support member 310 is positioned between alignment member 306and support member 308. The second support member 310 also includesthree attachment holes (only one of which is visible, 342), whichreceive pins, in a manner similar to that which has been described abovein connection with anti-buckling mechanisms 100 and 200. The attachmentholes 342 of the second support member 310 are positioned adjacent ends344 and 346, with one being located in the approximate center of secondsupport member 310.

Attachment hole 342 of one of the second support members 310 a that ispositioned adjacent end 344 is aligned with attachment hole 318 disposedin top element 314 of alignment member 306. A pin (not shown) isreceived within the aligned attachment holes 342/318 so as to hingedlyconnect one end of second support member 310 a to one end of alignmentmember 306. Attachment hole 342 of the same second support element 310 athat is positioned adjacent end 346 is aligned with attachment hole 318of another, successively arranged alignment member 306 a, as shown inFIG. 11, for example. More specifically, attachment hole 342 positionedadjacent end 346 is aligned with attachment hole 318 of the bottomelement 312 a. A pin (not shown) is received within the alignedattachment holes 342/318 so as to hingedly connect the other end of thesecond support member 310 a to one end of an adjacent alignment member306 a.

Attachment hole 336 that is positioned adjacent end 338 of the firstsupport member 308 b is also aligned with attachment hole 318 disposedin the bottom element 312 a of the alignment member 306 a. However, asshown in FIGS. 10 and 11, end 346 of the second support member 310 a ispositioned between the alignment member 306 a and first support member308 a. End 340 of the first support member 308 b extends away from theconnected second support member 310 a, and includes an attachment hole336 that is aligned with an attachment hole 318 disposed in the topelement 314 b of another, successively arranged, alignment member 306 b.Further, as shown in FIGS. 10 and 11, end 346 of another second supportmember 310 c is positioned between the alignment member 306 b and firstsupport member 308 b. A pin (not shown) is received within the alignedattachment holes 336/318 so as to hingedly connect the other end 340 ofthe first support member 308 b to ends of successively arranged adjacentalignment member 306 b and second support member 310 c.

In use, when the anti-buckling mechanism 300 is in its compressedconfiguration, as shown in FIG. 9, the alignment members 306 arepositioned adjacent one another, with all of the eyelets 330 aligned,thereby creating a channel for the flexible instrument, such as acatheter or sheath. Due to the interaction of the hinged connections ofthe first and second support members 308, 310, as the alignment members306 are being brought closer together, the top and bottom elements 312,314 of the alignment members 306 slide apart in a telescoping manner,thereby lengthening the alignment member 306, as shown in FIGS. 10 and12, represented by distance L₁. When in the fully compressed position,top element 314 will be positioned adjacent the end 324 of the bottomelement 312, as shown in FIG. 9. However, as the anti-buckling mechanism300 is expanded, the top and bottom elements 314 will slide together ina telescoping manner until end 334 of top element abuts wall 322 ofbottom element 312 and end 324 of bottom element 312 abuts wall 328 oftop element, as shown in FIGS. 10 and 11. In this configuration, thelength L of alignment members 306 is at its shortest length, as shown inFIG. 13.

The interaction between the hinged connections of the first and secondsupport members 308, 310, as well as the telescoping alignment member306, allows successively arranged support members 308, 310 to beselectively spaced apart from one another, thereby providing a frame toprevent buckling of a catheter 17 and/or sheath 30, as the catheter17/sheath 30 are advanced toward a patient. Further, this arrangement ofanti-buckling mechanism 300 ensures that the individual eyelets 330 ofsuccessive alignment members 306 are automatically aligned to form apathway for the catheter 17 and/or sheath 30. Thus, the design ofanti-buckling mechanism 300 is robust in reducing eyelet misalignment,while providing sufficient rigidity to the catheter 17 and/or sheath 30during use.

Another alternative embodiment of an anti-buckling mechanism 400 isillustrated in FIGS. 14 and 15. The anti-buckling mechanism 400 issimilar to the anti-buckling mechanism 300 in that it includes secondand third support members 408, 410, respectively, which are connectedtogether in the same manner as discussed above in connection with theanti-buckling mechanism 300. Further, alignment member 406 is alsocomprised of bottom and top elements 412 and 414, whereby the bottomelement 412 includes rails that are arranged to telescopically engagewith complementary elements disposed on a bottom surface of top element414 so as to selectively expand the length of the anti-bucklingmechanism 400 as it moves toward a compressed configuration (not shown).

However, instead of an eyelet, the top element 414 includes an openchannel section, which defines a groove 416 formed on a top surface 418of the top element 414, as shown in FIG. 15. The groove 416 is sized toreceive a flexible instrument therein, such as a catheter and/or asheath. The top element 414 further comprises a slidable closure member420. Closure member 420 is configured to close off groove 416. Tofacilitate operation of the closure member 420, a contoured portion 422may be provided to allow easy opening and closing of groove 416.

The previous exemplary embodiments for anti-buckling mechanisms 100, 200and 300 all require that the flexible instrument be threaded through theeyelets 112, 330 or apertures 222. The embodiment of anti-bucklingmechanism 400 allows for top loading/unloading of the flexibleinstrument. More specifically, a flexible instrument member may beloaded into each of the open channels in a direction perpendicular to anaxis of the open channels, for example perpendicular to the direction ofexpansion/collapse of the support frame.

The alignment members 406 may be secured to the support frame defined bythe pairs of support members 408, 410 such that a fixed rotationalposition of the supports, for example the channel section grooves 416,is maintained with respect to the other grooves 416 during bothexpansion and collapse of the support frame defined by the supportmembers 408, 410. The alignment members 406 are generally maintainedparallel to each other as the support frame defined by the first andsecond members 408, 410 is expanded and collapsed. Moreover, the supportframe is relatively simplified in arrangement as it employs single pairsof the support members 408, 410 to define a scissor-like arrangement,resulting in a relatively inexpensive and uncomplicated design for thesupport frame.

A further exemplary embodiment of an anti-buckling mechanism 500 ispartially shown in FIG. 16A. Anti-buckling mechanism 500 includes analignment member 510, a first support member 506, and a second supportmember 508. The first support member 506 is defined by first and secondends 512, 514, respectively. Each of the first and second ends 512, 514include inwardly extending flanges 516 that are positioned over the beamthat defines the first support member 506. A bottom surface of theflanges 516 is spaced away from a top surface 517 of the beam so as todefine a gap there between. Extending through the flanges 516 areattachment holes 518.

The second support member 508 is defined by first and second ends 520,522, respectively. Each of the first and second ends 520, 522 includes apair of inwardly extending flanges 524 that are spaced apart to define agap 526 there between. Extending upwardly from a top surface 528 of thesecond support member 508 is a mushroom pin 530. A contoured cut-out 531is formed within the support member 508 to accommodate a pin connectionthat serves to connect the first support member 506 to the alignmentmember 510.

The alignment member 510 includes an elongate slot 532 and an attachmenthole 534. The slot 534 engages with the mushroom pin 530, as will beexplained in further detail below. The attachment hole 534 may receive apin (not shown in FIG. 16A) that is mounted for rotation that is engagedto the first support member 506. The alignment members 510 areconfigured to support an eyelet or channel in any suitable mannerthrough which a flexible instrument such as a catheter and/or guide canextend. For example, as shown in FIG. 16B, an eyelet or open channelsection 540 may be defined by an alignment pin 542 that is received inthe attachment hole 534. Moreover, the attachment hole 534 mayfacilitate passive rotation of the eyelet 540 and/or the alignment pin542, thereby allowing a series of eyelets to maintain rotationalalignment with respect to an elongate member received within the eyelets540. In this manner, the eyelets 540 may provide anti-buckling supportradially with respect to the flexible member during expansion andcontraction of the support frame defined by the support members 506,508.

End 522 of a second support member 508 is engaged with end 512 of afirst support member 506 a such that flange 516 of the first supportmember 506 a is received between flanges 524 disposed at end 522 of thesecond support member 508. Attachment holes 518 of the first and secondsupport members 506 a and 508 are aligned. In one exemplaryconfiguration, a tapered pin (not shown) is inserted into the alignedattachment holes 518, thereby forming an external hinge point. The pinis sufficiently long enough to minimize an angle in the lateraldirection providing lateral bending, thereby achieving a tight lateralfit between the support members 506, 508.

Second support member 508 extends over the successive and adjacent firstsupport member 506. End 524 of second support member 508 would then beengaged with an end 514 of another first support member (not shown) thatwould be positioned to the right of first support member 506 in FIG.16A, in a manner similar to that which was described above (and as shownwith the attachment of 508 a to 506).

During assembly, the alignment member 510 is positioned over the head ofthe mushroom pin 530 and rotated such that the head of the mushroom pin530 extends through the slot 532. Once the mushroom pin 530 clears theslot 532 the alignment member 510 is rotated such that the mushroom headis not able to pass through the slot 532. However, a stem 536 of themushroom pin 530 is able to slide along the slot 532 during use of theanti-buckling mechanism 500. A pin (not shown) is inserted intoattachment hole 534 and engaged with first support member 506 such thatthe pin is free to rotate within the attachment hole 534.

In use, the first and second support member 506, 508 rotate about acenter point defined by the pin that is received within attachment hole534. The alignment member 510 is rotatable with respect to the secondbeam 508 due to the pin disposed in the attachment hole 534 and theslidable cooperation of mushroom pin 530 in slot 532. Accordingly, thealignment member 510 may remain aligned generally perpendicular to anaxis of insertion of a flexible instrument, thereby also maintaining agenerally axial alignment of the eyelets with respect to each other.Further, the eyelet on the alignment members 510 may receive differentsized guides for different size catheters, thereby providing greaterflexibility for procedures. For those embodiments where the eyelet isintegrally attached to the alignment members 510, different sizedalignment members may be used with support members 506 and 508.

The above arrangement of the anti-buckling mechanism 500 serve toprevent flexure through use of the long pins, while also allowing eyeletrotation to occur as the anti-buckling device 500 moves from an expandedconfiguration to a compressed configuration so as to keep the eyeletsaligned to an axis of insertion. Accordingly, increased guidancecapabilities, as well as increased buckle resistance (of the flexibleinstrument) may be achieved.

Further, as the exemplary illustrations provided herein use fewercomponents than traditional anti-buckling mechanisms (i.e. only two mainsupport members and the alignment member), a reduced part count leads tolower manufacturing costs, as well as ease of assembly.

Another alternative embodiment of an anti-buckling mechanism 600 isillustrated in FIG. 17. The anti-buckling mechanism 600 is similar tothe anti-buckling mechanism 500 in that it includes first and secondsupport members 606, 608 and an alignment member 610, respectively. Thefirst and second support members 606, 608 and alignment member 610 areconnected together in the same manner as discussed above in connectionwith the anti-buckling mechanism 500, for example the alignment member610 includes a slot 632 for receiving mushroom pin 630. However,alignment member 610 further includes a slider mechanism 650 on top ofthe alignment member 610. In one exemplary arrangement, slider mechanism650 has a catching latch 652 and a living hinge 654 that cooperate topull back slider mechanism 650 and expose an open channel (not shown)through alignment member 610 to place a catheter. More specifically,slider mechanism 650 is configured to allow the anti-buckling mechanism600 to be placed over a catheter or removed from a catheter during aprocedure, such as to allow for more insertion of a catheter when theanti-buckling mechanism 600 is in its collapsed configuration and closeto the insertion site. This selective removal feature eliminates wastedinsertion length and negates having to remove the catheter from thepatient's body to remove the anti-buckling mechanism 600. Further, thisfeature also permits the catheter to be inserted into the patient in thebeginning of a procedure, and then loading an anti-buckling mechanismonto the catheter.

Another alternative embodiment of an anti-buckling device 700 is shownin FIG. 18. Anti-buckling device 700 includes multiple cooperatingsupport members 706, 708 and an alignment member 710. One end of thefirst support member 706 is connected via a hinge to one of the secondsupport members 708 and a second end of the first support member 706 isconnected via a hinge to an adjacent second support member 708 a.Alignment member 710 pivots on support member 708. The slot 711 on thealignment member 710 engages with a post (not shown) on support member706 to maintain alignment member 710 rotationally constrained as thesupport members expand and contract. An elongate flexible instrumentwould pass through eyelets or apertures 709 on the alignment member 710.

A further exemplary embodiment of an anti-buckling device 800 is shownin FIGS. 19-21. The anti-buckling mechanism 800 is similar in somerespects to anti-buckling mechanism 500 and 600, in that both use a dualsupport member configuration with a center pivot point P and tapered pinexterior hinges H, as described above in connection with anti-bucklingmechanism 500 as shown in FIG. 16. However, instead of a separateeyelet, the anti-buckling mechanism 800 uses openings O in the centerpart of the support members 808 to form an eyelet. The opening O may beshaped to keep the most engagement of the catheter for support of agiven catheter dimension.

More specifically, looking at FIG. 19, anti-buckling mechanism 800includes first and second support members 806, 808, connected in themanner described above in connection with anti-buckling mechanism 500. Afirst raised land member 810 and second raised land member 812 aremounted to the support member 808 and form a channel or opening Otherebetween. A slider 814 can slide on support member 808 to close thechannel or opening O. As the first and second support members 806, 808pivot about pivot point P, they combine to provide a support frame forcatheter C which may be disposed within, as shown in FIGS. 20 and 21.Using just the first and second support members 806, 808 serves toreduce the number of parts, thereby reducing assembly time and costassociated with making and assembling the anti-buckling mechanism 800.

In FIG. 20, sliders 814 are in an open position, which allows selectiveremoval of the anti-buckling mechanism 800 during a procedure, or toploading of a catheter. In FIG. 21, sliders 814 are positioned in aclosed position. Yet another alternative to design in FIG. 19 would beto provide a static cover that would be positioned over the variableopening O.

FIGS. 22-24 illustrate a further exemplary embodiment of ananti-buckling mechanism 900. Anti-buckling mechanism 900 is similar toanti-buckling mechanisms 500-800, as shown in FIGS. 16-21, in thatanti-buckling mechanism 900 includes first and second support members906, 908 that are pivotally connected together about a center pivotpoint P and are connected together to form external hinges H in themanner described above. In this arrangement, however, each of supportmembers 906 includes an opening O extending therethrough. The opening Ois positioned to be off-center to the pivot point P. As may be seen,when the anti-buckling mechanism 900 is collapsed, as shown in FIG. 23,all of the openings O of successively arranged support members 906cooperate to form a channel for guiding a catheter C. Moreover,referring to FIGS. 22 and 24, when in an expanded configuration, theopenings O still remain aligned with one another and are sufficientlylarge enough that catheter C may still extend through, aligned with aninsertion site.

The configuration of FIGS. 22-24 provides double the support for thesame number of support members of the configurations shown above inFIGS. 14-21. Increased support can be important in certain circumstancesbecause buckling strength is inversely proportional to the square ofunsupported length. As the openings O are arranged off-center to thecentral pivot point P, the openings O are similar to the variable eyeletconfiguration discussed above in connection with FIGS. 19-21, in thatthey are points of contact and do not provide a constant width.

The anti-buckling mechanism 900 decreases the space between supportmembers 906, 908. Because this design provides increased support overother designs, the number of overall support members may be reduced.This configuration will therefore allow wasted length to be decreased ifthe catheter is fully inserted into the body. Because the buckle lengthis reduced, buckle resistance is increased.

A final exemplary arrangement of an anti-buckling mechanism 1000 isshown in FIGS. 25 and 26. In this arrangement, dual beams 1006, 1008 areeach provided with teeth 1010 which cooperate to facilitate extensionand collapse of the beams 1006, 1008 in a manner similar to a gear. Toensure that the beams 1006, 1008 rotate symmetrically, the teeth 1010are slightly offset, similar to a geared protractor. An eyelet 1012 iscentered as openings in between the teeth 1010. As may be seen in FIG.26, the teeth 1010 defined by each of the beams 1006, 1008 (only beam1006 shown in FIG. 26) are spaced apart from one another leaving a gap1014 into which eyelet 1012 may be disposed. The eyelets are parallel tothe axis of insertion. In an alternative arrangement (not shown), eyelet1012 may be placed on a top or bottom of a coupler 1016 of the gears1010. Eyelets 1012 positioned on the top of the coupler may be fixed orhaving opening features (such as snap-on or sliders) to enableanti-buckling mechanism 1000 to be added or removed during a procedure.

The anti-buckling mechanism 1000 keeps eyelets 1012 centered, increasingbuckling resistance, reduces part count, and eases assembly with use oflocking features. While the cooperating teeth are only shown at thecenter of the beam interaction, it is understood that gears may also beused at the outer hinges, and there may be more center gears employedthan the gears 1010 shown, as well as concentric gears.

In some embodiments, exemplary anti-buckling supports may be integratedwithin an instrument driver or remote catheter manipulator (RCM). Asshown in FIGS. 27-39, an exemplary anti-buckling support assembly 2820is illustrated integrated into an exemplary RCM 2800. The RCM 2800 maybe employed in conjunction with any catheter system, for example similarto the instrument driver 16 as described above in system (S) in FIGS.1A-1C.

As shown in FIGS. 27, 35 and 36, the RCM 2800 may include one or moreanti-buckling supports, in this case scissor mechanism 2820, which isgenerally incorporated internally to the RCM 2800. In this manner, thescissor mechanism 2820 is placed outside of the sterile field, and doesnot need to be replaced after each procedure. More specifically, the RCM2800 includes a top deck 2814 and cover 2850, which generally define anouter cover of the RCM 2800. A sterile drape may be laid over the deck2814 or interfaced with supports 2808, 2802, and 2812. The supports2808, 2802, 2812 may interface with an elongate member (not shown) inorder to provide anti-buckling support to the elongate member. In thismanner, the supports 2808, 2802, 2812 each translate the lateral supportof the scissor mechanism 2820 across the sterile boundary to theelongate member. The supports 2808, 2802, 2812 may directly interfacewith the elongate member or may provide the mounting locations where aone-piece, foldable structure anti-buckling mechanism may attach, aswill be described in further detail below in connection with FIG. 38.The RCM 2800 may include a splayer interface 2860 configured to drive asplayer associated with the elongate member. It should be noted that thealternative anti-buckling support structures such as that shown in FIGS.37-40 may also be used instead of scissor mechanism 2820.

Turning now to FIGS. 27-34, internal construction of the exemplary RCM2800 is explained in further detail. The RCM 2800 includes a cathetermounting plate 2804 a and idler mounting plate 2804 b, which areillustrated in a partially retracted position in FIG. 27. Ananti-buckling support, here a scissor mechanism 2820, is integratedwithin the RCM 2800 and may connect to both carriages 2804, for exampleconnecting catheter mounting plate 2804 a to idler mounting plate 2804b. A similar anti-buckling support, for example a scissor mechanism,could be mounted forward of the idler mounting plate 2804 b, attachingto a sheath mounting plate assembly (or carriage if designed to moveindependently). As shown in FIG. 28, the idler mounting plate 2804 b maytravel in connection with the catheter mounting plate 2804 a. Forexample, translation of the idler mounting plate 2804 b may occur at a1:2 ratio with respect to the catheter mounting plate 2804 a. Idlermounting plate 2804 b employs linear bearings 2806 mounted to linearshafts, which also support the catheter mounting plate 2804 a. The idlermounting plate 2804 b could be designed such that portions of themounting plate 2804 b extend above a deck 2814 (which may generallyfunction as a top cover) of the RCM 2800, similar to the cathetermounting plate. Additionally, the idler mounting plate 2804 b may bepositioned such that associated risers 2808, 2812, and 2802, which areconfigured to carry an elongate member, for example a catheter, arepositioned near the center of the catheter mounting plate and sheathmounting plate, as shown in FIG. 29. The support risers 2802 extendupwards above the deck 2814. In this manner, the idler mounting plate2804 b may translate at a 50% rate with respect to the catheter mountingplate 2804 a. A sterile drape (not shown) may interface with the RCM2800 at the riser portions 2812 of the idler mounting plate 2804 b,assuring that the center of the drape travels at the same 1:2 ratio asthe catheter mounting plate 2804 a. A catheter eyelet bushing (notshown) may be mounted to an external surface of the drape at the idlermounting plate interface, thus reducing the buckle distance by 50%.Additional mini-carriages with similar riser features can be insertedbetween the idler mounting plate and the catheter mounting plate, andbetween the idler mounting plate and the sheath mounting plate. Thesewould provide the disposable's mounting support at each eyelet, secondeyelet, or each third eyelet as will be described below in connectionwith FIGS. 37-39.

Turning now to FIG. 29, catheter mounting plate support risers 2808 areprovided, along with intermediate carriages with anti-buckling supportrisers shown 2812. In this example, the support risers 2812 are coupledto every second scissor cross pivot point 2860. In other exemplaryapproaches, support risers 2812 may be aligned together (coupleddirectly together). In the approach illustrated, a higher density ofcontact points to support the anti-buckling device eyelets is achieved,without increasing the linear length requirements.

Referring to FIGS. 30 and 31, the deck (i.e. top cover plate) 2814 isillustrated. Upon installation of the deck 2814, only the eyelets 2816of the riser supports are visible above the deck 2814. In this manner,an elongate member may be received within the eyelet supports 2816 suchthat the elongate member is supported above the deck 2814, for exampleoutside of the RCM 2800, and within the sterile filed. Accordingly, asterile drape may generally be supported by the deck 2814. It should benoted that an additional anti-buckling support, for example scissormechanism 2820, may typically be provided with dedicated support risersin front of the mechanism 2820 (i.e. the right in FIG. 30), between theidler mounting plate and the sheath (bearing blocks shown). As shown inFIG. 31, the support risers 2802, 2808, 2812 are generally positioned atthe same height as the guide mounting plate, so the sterile drape willsit flat, for example upon the deck 2814.

Turning now to FIGS. 32-34, movement of the scissor assembly 2820 withinthe RCM 2800 is illustrated in further detail. As shown in FIGS. 32 and34, the RCM 2800 is illustrated with the catheter and idler mountingplates 2806 in a fully extended, for example full catheter insertion,position. The scissor assembly 2820 is fully compressed, and the bearingblocks 2806 are almost in contact with each other. The mini-carriagebearing blocks 2806 are aligned, however the risers 2802, 2808, 2812 aredesigned with forwards/backwards offsets, for example in an axialdirection or parallel to the direction of movement of the bearing blocks2806, to enable attachment of different eyelet positions to the elongatemember (not shown in FIG. 32). As shown in FIG. 33, the catheter andidler mounting plates 2806 may be extended away from one another, forexample as insertion of the elongate member occurs, thereby providinganti-buckling support to an elongate member (not shown in FIGS. 32-34).

Accordion-Like Anti-Buckling Mechanisms

Turning now to FIGS. 37-39, another exemplary arrangement of ananti-buckling mechanism 1120 is described in detail. Anti-bucklingmechanism 1120 may be a generally one-piece, foldable structure thatselectively extends and retracts to reduce, inhibit, or prevent bucklingof an elongate member 300, for example a catheter or sheath. As notedabove, the elongate member 1100 may be actuated by a splayer 1102.

Anti-buckling mechanism 1120 may be formed from a plastic material, forexample similar to material commonly employed as a sterile barrier (notshown) or any other type of flexible metal or polymer known to oneskilled in the art. The anti-buckling mechanism 1120 may initially beformed of a monolithic single piece that is subsequently folded and/orcut to provide an extensible support structure. More specifically, theanti-buckling mechanism 1120 may be formed of material that can be cutand formed to create multiple eyelets 1122 to support the elongatemember 1100. The material thickness can vary depending on the designrequirement. Thicker materials will increase overall rigidity to betterresist buckling but the thicker materials, when fully compressed, willoccupy more space on the catheter or sheath. The eyelets 1122 could bemolded or heat-formed into a funnel shape to provide low frictionbushings configured to receive the elongate member 1100. The eyelets1122 may be formed in a support 1124. An accordion section 1126 allowingthe distance between the eyelet supports 1124 to expand or contract maybe positioned between each eyelet support 1124. The model shown in FIGS.37-39 generally incorporates accordion sections 1128, 1130 in two planeson either side of the eyelets. The provision of accordion sections 1128,1130 in two separate planes may provide additional bi-directionalstability that in turn increases the lateral rigidity of the elongatemember 1100, thereby reducing the probability of buckling of theelongate member. More specifically, the accordion section 1128, as shownin FIG. 37, may generally be aligned in a first plane B while theaccordion section 1130 is aligned in a second plane C. In one example,the planes B, C may be generally perpendicular to one another, howeverthe planes B, C may define any non-zero angle α there between that isconvenient, as shown in FIG. 37. Each according section 1128, 1130 mayinclude two members 1128 a, 1128 b, and 1130 a, 1130 b, respectively, asshow in FIG. 38. The members 1128 a and 1128 b may be hinged along afold line 1134, while the members 1130 a and 1130 b are hinged along afold line 1136, as shown in FIG. 38.

The anti-buckling mechanism may be generally disposable, and may mountto multiple locations on the RCM through a sterile drape (not shown inFIGS. 37-39). The RCM may drive each of the eyelet supports 1124, eachsecond eyelet support 1124, or each third eyelet support 1124, dependingon the density of eyelet supports 1124 and corresponding eyelets 1122,the density of the mini-carriages, and the anti-buckling stability ofthe accordion feature. For example, the anti-buckling mechanism 1120 maybe used in conjunction with the support risers discussed above inrelation to FIGS. 27-36, in place of or in addition to the scissor-likeanti-buckling mechanism positioned within the RCM. In this manner, theanti-buckling support 1120 may be optimized to provide a desired levelof anti-buckling support and axial stiffness.

In some examples, the anti-buckling mechanism 1120 advantageously may beformed of a plastic material or other material capable of being formedof a generally single, monolithic piece that is subsequently cut,folded, molded etc. to form the general configuration illustrated inFIGS. 38 and 39. In such examples, the anti-buckling mechanism 1120 mayadvantageously be formed using injection molding or other relativelyinexpensive methods. Accordingly, costs of producing the anti-bucklingmechanism 1120 may be reduced compared with traditional methods ofmanufacturing anti-buckling supports, and thus even where theanti-buckling mechanism 1120 is within a sterile field associated with asurgical procedure requiring disposal at the conclusion of theprocedure, overall system costs may be reduced.

Referring now to FIG. 37, an exemplary anti-buckling mechanism is shownmounted to an elongate member 1100, for example a catheter. Theanti-buckling support 1120 may be pre-attached to a sterile drape (notshown) if associated sheath and guide splayers are shipped separatelyand installed separately on the RCM. Alternatively, the anti-bucklingsupport 1120 may be shipped as a separate unit or shipped pre-attachedto the catheter and/or sheath.

The eyelet supports 1124 may be formed perpendicular to horizontalsupports 1142 which extend laterally with respect to the elongate member1100, as shown in FIG. 38. Additionally, the horizontal supports 1142may include stiffening ribs (not shown), for example to increase anoverall stiffness of the anti-buckling support 1120 in axial and/orlateral directions with respect to the elongate member 1100. The eyelets1122 may themselves be heat-formed, for example in a two-sided funnelshape, to aide installation of the elongate member 1100, and reducefriction in both directions with the elongate member 1100. The accordionsections 1128, 1130 may also be designed to provide a proper livinghinge spring force. For example, spring force provided by the hingesdefined by fold lines 1134, 1136, as shown in FIG. 38, may be adjustedby perforating or thinning the material of the anti-buckling support1120.

The accordion sections 1128, 1130 may extend between mounting locations1140, as shown in FIG. 38. Two mounting locations 1140 may be disposedon either side of horizontal supports 1142, which extend laterally withrespect to the elongate member 1100. The mounting locations 1140 may beprovided to generally facilitate mounting the anti-buckling mechanism1120 to RCM support risers (not shown in FIGS. 37-39) as discussed abovein accordance with FIGS. 27-36. In one example, the mounting locationsmay generally snap into position on an RCM through the sterile drape,for example similar to sterile adapters (not shown) for snapping intoguide and sheath carriages. Alternatively, a mechanism utilizing screwsmay couple the anti-buckling mechanism to the RCM.

The anti-buckling support 1120 may be folded and heat staked to retainits shape. The accordion sections 1128, 1130 generally provide “legs” oneither side, which generally buckle axially. At the same time, lateralsupport is generally provided by the horizontal supports 1142. In theexample shown, buckling would occur in the two planes B, C on eitherside of the elongate member 1100. The two-plane configuration maygenerally provide more support to constrain the catheter shaft frombuckling.

Turning now to FIG. 40, a schematic illustration of an exemplaryanti-buckling support is provided, which generally illustratescomponents of an exemplary anti-buckling support in the abstract, whichmay be generally applied to a representative catheter system (not shownin FIG. 40). The anti-buckling support 4100 includes a base plate 4102and a rail 4104, which extends away from the base plate 4102. The baseplate 4102 may support a splayer or other instrument driving apparatus(not shown) configured to facilitate control of an elongate member (notshown in FIG. 40) supported by the anti-buckling mechanism 4100. Therail 4104 may be fixed to the base plate 4102. The rail 4104 carries amultiple member supports 4106, which are moveable along the rail 4104.Each of the member supports 4106 define an eyelet 4108, which isconfigured to support the elongate member (not shown in FIG. 40). Theelongate member may be snapped into the open eyelet 4108 through asterile drape. This allows the entire anti-buckling support structure4100 to remain outside of the sterile field. More specifically, when theelongate member inside the sterile field is snapped into place, eacheyelet 4108 may generally prevent lateral movement of the elongatemember relative to the rail 4104. As insertion of the elongate membermay generally be driving in a direction parallel to the rail 4104, themoveable member supports 4106 may generally reduce buckling of theelongate member by preventing or minimizing lateral movement of theelongate member.

Axial movement of the member supports 4106 may be dictated by movementof the elongate member, for example each member support 4106 may befixed axially to the elongate member and move passively with theelongate member during insertion. Alternatively, the member supports4106 may be separately driven. In either case, accordion members 4110 a,4110 b (collectively, 4110) may be provided which may bias movement ofthe member supports 4106 and provide additional lateral support for theelongate member. More specifically, each member support 4106 may beconnected to an adjacent member support 4106 by a first accordionsupport 4110 a and a second accordion support 4110 b. The first andsecond accordion supports 4110 a, 4110 b are linked via a hinge 4112.The stiffness of hinge 4112 can be adjusted as required. Stiffer hingeswill require more axial force to compress them but will serve to keepeach of the member supports 4106 equidistant as the elongate member isadvanced and the entire support structure 4100 is compressed axially

Channel-Based Anti-Buckling Mechanisms

Referring now to FIGS. 41 and 42, an exemplary illustration of a supportassembly 4200 for supporting an elongate member 4202 is shown. Thesupport assembly 4200 generally includes one or more rails, whichprovide anti-buckling support to the elongate member 4202. As will bedescribed further below, in some exemplary illustrations an elongatemember 4202 is supported by a generally single rail, while in otherexemplary approaches multiple rail sections may be employed.

In one exemplary illustration, the elongate member 4202 may include acatheter sheath and leader catheter supported by corresponding railsections. For example, in the exemplary approach shown in FIGS. 41-45,two rails 4204, 4214 are provided to support a catheter leader and asheath catheter, respectively. More specifically, a leader rail 4204 mayextend from a distal end 4206 of a leader splayer 4208 to a proximal end4210 of a sheath splayer 4212. The leader rail 4204 generally defines achannel, as will be described further below, which laterally supports acatheter leader included in the elongate member 4202. A sheath rail 4214protrudes from a distal end 4216 of a sheath splayer 4212, and similarlydefines a channel, as will be described further below, which laterallysupports a sheath catheter included in the elongate member 4202. Thesheath splayer 4212 and leader splayer 4208 may include a sheath railmount 4218 and a leader rail mount 4220, respectively, which allow thesheath splayer 4212 and leader splayer 4208 to translate along theirrespective rails 4214 and 4204. The sheath rail mount 4218 and leaderrail mount 4220 may generally secure the sheath rail 4214 to the sheathsplayer 4212 and the leader rail 4204 to the leader splayer 4208,respectively. The leader rail 4204 and sheath rail 4214 may beconfigured to allow for the elongate member 4202 to be slideably heldwithin the rails 4204 and 4214. For example, the sheath splayer 4212 andleader splayer 4208 may insert and/or rotate a catheter sheath andleader catheter, respectively, of the elongate member 4202. Accordingly,the catheter sheath and leader may travel axially along the sheath rail4214 and leader rail 4204, respectively.

Support assembly 4200 may further include a first roller assembly 4222(or leader roller assembly) and a second roller assembly 4224 (or sheathroller assembly). The support assembly 4200 may also include a leadercurtain 4226 and a sheath curtain 4228. The leader roller 4222 mayselectively roll up the leader curtain 4226 and the sheath roller 4224may selectively roll up the sheath curtain 4228, respectively. Thecurtains 4226, 4228 may be used to prevent the elongate member 4202 frombuckling and/or being dislodged or otherwise removed from the channelsof the rails 4204, 4214, respectively, as will be described furtherbelow.

The sheath rail 4214 may extend from the sheath splayer 4212 to apatient insertion site (not shown). More specifically, a proximal end4232 of the sheath rail 4214 may be coupled to the distal end 4216 ofthe sheath splayer 4212 and the distal end 4234 of the sheath rail 4214may be coupled to or otherwise be disposed adjacent the patientinsertion site. In one exemplary approach, the distal end 4234 of thesheath rail 4214 may be fixed to the patient insertion site using acoupling device, such as a flexible nylon strap or a stabilizer. Thecoupling device or strap may be attached to a patient patch (not shown),which may in turn be adhesively secured to the patient. In otherexemplary illustrations, other coupling devices may be employed tosecure the distal end 4234 of the sheath rail 4214 near the patientinsertion site.

Referring to FIG. 42, a cross-sectional view of an exemplary leader rail4204 and/or sheath rail 4214 is shown with a semi-circular catheterchannel 4240 and a rectangular rail mount channel 4242. Both the leaderrail 4204 and sheath rail 4214 may have a similar configuration to thatshown in FIG. 42, although the leader rail 4204 may define relativelysmaller interior dimensions consistent with the smaller size of theleader catheter in comparison to the sheath catheter. While the channels4240, 4242 are shown as semi-circular and rectangular, respectively, anyshape or configuration may be employed that is convenient, for examplethe channels may be sized and shaped to receive an elongate member. Theelongate member 4202 may be disposed within the catheter channel 4240such that the central axis of the elongate member 4202 coincides withthe center axis of the catheter channel 4240 and/or the center of thesemi-circular shape of the catheter channel 4240. The catheter channel4240 may be sized to receive the elongate member 4202 holding itsufficiently secure while providing enough clearance to allow it toslide within the catheter channel 4240 with minimal friction.Accordingly, the catheter channel 4240 generally provides lateralsupport to the elongate member 4202, thereby preventing buckling of theelongate member 4202, while also allowing axial movement of the elongatemember 4202 to permit insertion and retraction. The catheter channel4240 of the leader rail 4204 may be sized smaller than the catheterchannel 4240 of the sheath rail 4214 to accommodate a smaller diameterleader catheter (in comparison to the sheath catheter).

Referring now to FIG. 43, an enlarged view of the sheath splayer 4212 isshown. The rail mount channel 4242 (not shown in FIG. 43) of the sheathrail 4214 may couple the sheath rail 4214 to the sheath rail mount 4218and allow the sheath splayer 4212 to translate axially along the sheathrail 4214. The sheath rail mount 4218 not only couples the sheathsplayer 4212 to the sheath rail 4214 but may enclose the elongate member4202 in place in all radial directions. As shown in FIG. 45, anexemplary leader splayer 4208 and leader rail mount 4220 may be similarin construction to sheath splayer 4212 and the sheath rail mount 4218,and may support the leader catheter in a similar manner to the supportprovided to a leader catheter by the sheath splayer 4212 and sheath railmount 4218. Moreover, the leader rail 4204 may be coupled to the leaderrail mount 4220 to allow the leader splayer 4208 to translate axiallyalong the leader rail 4204.

The elongate member 4202, for example the leader catheter and/orcatheter sheath, may be held within the catheter channel 4240 by thesheath rail mount 4218 or the leader rail mount 4220, however theremaining length of the elongate member 4202 may still be free to movein a vertical direction which might result in unwanted buckling of theelongate member 4202 during catheter insertion.

In order to prevent this vertical buckling, a leader curtain 4226 and asheath curtain 4228, as shown in FIG. 41, may be provided to enclose thecatheter channel 4240 along the length of the leader rail 4204 and thesheath rail 4214, respectively, as will be described further below. Theleader curtain 4226 and sheath curtain 4228 may each be selectivelyinserted into the leader rail 4204 and sheath rail 4214, respectively,to provide further anti-buckling support to the elongate member 4202disposed in the rails 4204 and 4214. Additionally, as will be describedfurther below, the curtains 4226, 4228 may each be generally rolled upon a mount adjacent their respective rails 4214, 4204 to allow forselective deployment of the curtains 4226, 4228 along the rails 4214,4204.

In one example, the curtains 4226, 4228 may be mounted at distal ends ofthe rails 4214, 4204, respectively. More specifically, referring now toFIGS. 43 and 44, in one exemplary illustration, a first roller assembly4222 for rolling up the leader curtain 4226 and a second roller assembly4224 for rolling up the sheath curtain 4228 are provided. The firstroller assembly 4222 may be mounted to the sheath splayer 4212, as shownin FIG. 43, and the second roller assembly 4224 may be mounted to thesheath rail 4214, as shown in FIG. 44. The first roller assembly 4222may be configured to roll up the leader curtain 4226 as the leadersplayer 4208 moves toward the sheath splayer 4212. The second rollerassembly 4224 may be configured to roll up the sheath curtain 4228 asthe sheath splayer 4212 moves toward the distal end of the sheath rail.The leader curtain 4226 and/or the sheath curtain 4228 may be containedwithin the rail mount channel 4242 of their respective rails 4204, 4214.

FIG. 46 shows another exemplary channel type anti-buckling mechanism4700. This variation includes a relatively long channel 4744 positionedabove a sterile drape 4746, with both leader splayer 4708 and sheathsplayer 4712 extending through the sterile drape 4746. The long channel4744 is generally a single continuous rail, in contrast to otherapproaches using two separate rails. Accordingly, the channel 4744 ofthe mechanism 4700 extends as a generally single, monolithic piecethrough both the leader splayer 4708 and sheath splayer 4712. Thechannel 4744 may passively support the elongate member 4202. Forexample, the channel 4744 may remain in a fixed position with respect toa patient 4747 (not shown in FIG. 46). Accordingly, in such examples theelongate member 4202 may move axially with respect to the channel 4744as the elongate member 4202 is inserted into or retracted out of thepatient 4747. In other approaches, the channel 4744 may be selectivelymoveable, for example in coordination with the elongate member 4202.

FIGS. 47A and 47B are perspective and end-on cross-sectional views,respectively, of an alternative embodiment of channel 4744. FIG. 47B thechannel 4744 with an elongate member 4702, for example a catheter,installed. While not specifically shown in FIGS. 46, 47A, and 47B, thechannel 4744 may be provided with one or more curtains for providingvertical anti-buckling support to an elongate member 4702 insubstantially a similar manner as that described above regarding supportassembly 4200.

In some exemplary approaches, a split cover may be used to preventegress of an elongate member from an exemplary rail or channel. Forexample, as shown in FIG. 47B, a split cover 4750 a, 4750 b is providedalong an upper open end of the channel 4744. The split cover generallyprevents an elongate member 4702 disposed within the channel 4744 frombuckling vertically, for example in a manner in which some portion ofthe elongate member 4702 would become dislodged from the generallyU-shaped interior of the channel 4744. The two sections of the cover4750 a, 4750 b may generally be compliant to allow insertion and/orretraction of the elongate member 4702 into the channel 4744, while alsobeing sufficiently stiff to resist buckling of the elongate member 4702when it is contained within the channel 4744.

Referring now to FIG. 48, an exemplary support mechanism 4700 may alsoinclude a sterile adaptor 4751 coupled to the channel 4744. The sterileadaptor 4751 may be coupled via gears (not shown), which may drive thesterile adaptor 4751 along the channel 4744. In this manner, the sterileadaptor 4751 may be moved along the channel 4744, for example to driveinsertion and/or retraction of an elongate member. The leader splayer orthe sheath splayer may be mounted to the sterile adaptor 4751. Thesterile adaptor 4751 may generally be disposed on an upper side of thechannel 4744 and underneath a splayer (not shown in FIG. 48). In someembodiments, the sterile adaptor 4751 may be coupled to a sterile drape(not shown in FIG. 48) that covers a remaining portion of the roboticcatheter system and generally provides a barrier between the roboticcatheter system and the sterile field.

Turning now to FIGS. 49A and 49B, an exemplary support assembly isillustrated. The support assembly may include a sheath splayer 4708 anda leader splayer 4709, each of which is mounted to the channel 4744. Thecatheter splayer 4708 may include jaws (not shown), which selectivelyengage the channel 4744, thereby selectively fixing the sheath splayer4708 to the channel 4744. More specifically, the jaws may allowselective fixing of the channel 4744 to a splayer, temporarilypreventing axial translation of the splayer along the channel 4744. Thesheath splayer 4708 may otherwise be axially movable with respect to thechannel 4744.

Additionally, the splayer 4708 may move axially with respect to theleader catheter 4760 b, which extends from the leader splayer 4709. Morespecifically, as the splayer 4708 moves along the channel 4744 and theelongate member 4760 b, the elongate member 4760 b is generally taken upout of the channel 4744 by the sheath splayer 4708 and placed back intothe channel 4744. In this fashion, the elongate member 4760 b generallyremains supported within the channel 4744 save for the portion of theelongate member 4760 b that is disposed within the sheath splayer 4708.

The channel 4744 may have a cover for selectively enclosing the elongatemember 4760 a and/or 4760 b within the channel 4744. For example, thechannel 4744 may include a split top, or the channel 4744 may have aroll up cover similar to that described above. The cover may generallyfacilitate movement of the catheter leader 4760 b out of and back intothe channel 4744 during axial movement of the sheath splayer 4708 withrespect to the channel 4744 and catheter leader 4760 b.

The exemplary rail systems described herein, for example the rails 4204and/or 4214, as well as the long channel 4744, generally minimize wastedlength of a catheter system, especially in comparison to folding supportmechanisms. More specifically, a comparable folding or scissor typesupport mechanism necessarily takes up at least some axial space evenwhen fully compressed, resulting in some length of the elongate memberor catheter that must remain outside the patient. By comparison, asplayer slidably mounted on one of the exemplary rails described herein,for example splayer 4218, can translate axially up to the patientinsertion site along the rail 4214, leaving a minimal amount of space,if any, in between the splayer and the patient insertion site.

The mechanisms and methods described herein have broad applications. Theforegoing embodiments were chosen and described in order to illustrateprinciples of the methods and apparatuses, as well as some practicalapplications. The preceding description enables others skilled in theart to use methods and apparatuses in various embodiments and withvarious modifications, as suited to the particular use contemplated. Inaccordance with the provisions of the patent statutes, the principlesand modes of operation of this disclosure have been explained andillustrated in exemplary embodiments.

It is intended that the scope of the present methods and apparatuses bedefined by the following claims. This disclosure may be practicedotherwise than is specifically explained and illustrated, withoutdeparting from its spirit or scope. Various alternatives to theembodiments described herein may be employed in practicing the claims,without departing from the spirit and scope as defined in the followingclaims. The scope of the disclosure should be determined, not withreference to the above description, but should instead be determinedwith reference to the appended claims, along with the full scope ofequivalents to which such claims are entitled.

Future developments may occur in the arts discussed herein, and thedisclosed systems and methods may be incorporated into such futureexamples. Furthermore, all terms used in the claims are intended to begiven their broadest reasonable constructions and their ordinarymeanings as understood by those skilled in the art unless an explicitindication to the contrary is made herein. In particular, use of thesingular articles such as “a,” “the,” “said,” etc. should be read torecite one or more of the indicated elements unless a claim recites anexplicit limitation to the contrary. The following claims define thescope of the invention and that the method and apparatus within thescope of these claims and their equivalents be covered thereby. In sum,the invention is capable of modification and variation and is limitedonly by the following claims.

What is claimed is:
 1. A device for preventing buckling of a flexibleelongate member during insertion of the flexible elongate member, thedevice comprising: a support frame comprising a first end, a second end,and multiple pairs of support members, wherein the support frame isconfigured to reversibly move from a collapsed configuration to anexpanded configuration when the first and second ends are moved awayfrom each other; and multiple open channels coupled to the multiplepairs of support members of the support frame, wherein the multiple openchannels each comprise a top opening at a top of each of the multipleopen channels that is configured to allow the flexible elongate memberto be top loaded into the top opening of each of the multiple openchannels such that the flexible member is delivered into the multipleopen channels in a direction that is transverse to a longitudinal axisthat extends through the multiple open channels, and wherein themultiple open channels are maintained in an axial alignment as thesupport frame is moved between the expanded and collapsedconfigurations.
 2. The device of claim 1, wherein the support framecomprises an alignment member.
 3. The device of claim 2, wherein thealignment member defines one of the multiple open channels.
 4. Thedevice of claim 2, wherein the alignment member includes a slidableclosure member configured to slide laterally with respect to themultiple open channels to close or open the multiple open channels. 5.The device of claim 1, wherein each of the multiple open channels issecured to one of the pairs of support members, such that each openchannel is maintained in a substantially fixed rotational position withrespect to its corresponding pair of support members.
 6. The device ofclaim 1, further comprising the flexible elongate member, wherein eachof the multiple open channels has a diameter that is larger than anouter diameter of the flexible elongate member.
 7. The device of claim1, further comprising at least one closure member configured toselectively cover one of the multiple open channels.
 8. The device ofclaim 7, wherein the at least one closure member is slidably connectedto the one of the multiple open channels.
 9. The device of claim 8,further comprising multiple alignment members, each defining one of themultiple open channels, wherein the at least one closure member isconfigured to slide laterally with respect to the one of the multipleopen channels.
 10. The device of claim 1, wherein a diameter of each ofthe multiple open channels is sufficiently larger than a diameter of theflexible elongate member to allow the elongate member to maintain theaxial alignment when the first and second ends are moved with respect toeach other.
 11. The device of claim 1, further comprising a firstcoupler positioned on the first end of the support frame, and a secondcoupler positioned on the second end of the support frame, wherein thesecond coupler is configured to position the flexible elongate member.12. The device of claim 1, wherein the multiple open channels eachcomprise an open perimeter for receiving the flexible elongate membertherein.